Osteoarthritis of the KneeNCT01611441
Investigation of Specific Protein/Markers in Patients With Osteoarthritis of the Knee Having a Total Knee Replacement
An observational study of Osteoarthritis of the Knee, run by AstraZeneca at 6 sites in 2 countries.
Trial summary
The main purpose of the study is to better understand how specific proteins/markers in blood, urine, synovial fluid (a lubricating fluid secreted by the membrane lining the joints), and joint tissue are involved in osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- How many people
- 125 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Dec 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary and secondary care clinics
Who may be able to join
- Patients who will undergo a total knee replacement due to osteoarthritis.
- Symptoms of the knee for at least 6 months prior to study start.
Who cannot join
- Key-hole surgery performed on target knee within 3 months prior to study start.
- History of disorders in which part of the immune system is missing or defective.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Canada3 sites
Research Site
Montreal
Research Center
Newmarket
Research Site
Québec
About this study
Official title: Investigation of Biomarkers in an Exploratory Study in Patients With Osteoarthritis of the Knee Undergoing Total Knee Replacement Surgery
The main purpose of the study is to better understand how specific proteins/markers in blood, urine, synovial fluid (a lubricating fluid secreted by the membrane lining the joints), and joint tissue are involved in osteoarthritis of the knee. The aim is to investigate if there is a correlation between x-ray results, specific proteins/markers and different types of pain in patients with osteoarthritis of the knee. The study consists of 3 visits over 3-20 days and the last visit will be the day of surgery.
Read the detailed description
Investigation of Biomarkers in an Exploratory Study in Patients with Osteoarthritis of the Knee Undergoing Total Knee Replacement Surgery
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoarthritis of the knee, Biomarkers
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with osteoarthritis of the knee | Patients with osteoarthritis of the knee undergoing total knee replacement surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with upregulation of IL-6 or the IL-6 signalling pathway in the knee.
Measured: 3-20 days prior to day 1 (surgery) and day 1 (surgery) .
Secondary outcomes (5)
Biomarkers in synovial fluid, synovial membrane, and cartilage.
Measured: Day 1 (surgery).
Biomarkers in blood and urine.
Measured: 3-20 days prior to day 1 (surgery) and day 1 (surgery).
Biomarkers by Magnetic Resonance Imaging (MRI).
Measured: 1-5 days prior to day 1 (surgery).
Polymorphisms in 10 specific genes.
Measured: 3-20 days prior to day 1 (surgery) or at any time in the study.
WOMAC (Western Ontario and McMaster Osteoarthritis Index) variables and NPQ (Neuropathic Pain Questionnaire) variables.
WOMAC consists of 3 subscales with a total of 24 questions regarding pain, stiffness and difficulty in performing daily activities. A VAS (Visual Analogue Scale) will be used for the patient to report the severity of the symptoms on the target knee. Endpoints are marked "No pain" (0 mm) and " Extreme pain" (100 mm) on a paper PRO (Patient Reported Outcome) questionnaire. The less pain scored the better outcome.
NPQ accesses 12 different pain intensities. 0 represents no intensity and 100 represents worst intensity imaginable. The less intensity the better outcome.
Measured: 3-20 days prior to day 1 (surgery) and 1-5 days prior to day 1 (surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rolf Karlsten, MD, PHD, Study director, AstraZeneca R&D Sodertalje, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611441
- Sponsor's protocol ID
- D2285M00029
- Other IDs
- D2285M00029
- Status last verified
- Jun 2012
- First submitted
- 31 May 2012
- Last updated
- 27 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Radojcic MR, Thudium CS, Henriksen K, Tan K, Karlsten R, Dudley A, Chessell I, Karsdal MA, Bay-Jensen AC, Crema MD, Guermazi A. Biomarker of extracellular matrix remodelling C1M and proinflammatory cytokine interleukin 6 are related to synovitis and pain in end-stage knee osteoarthritis patients. Pain. 2017 Jul;158(7):1254-1263. doi: 10.1097/j.pain.0000000000000908.
PubMed 28333699
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Biomarkers in an Exploratory Study in Patients With Osteoarthritis of the Knee Undergoing Total Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT01611441
- Acronym / sponsor ID
- D2285M00029
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoarthritis of the knee, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the study is to better understand how specific proteins/markers in blood, urine, synovial fluid (a lubricating fluid secreted by the membrane lining the joints), and joint tissue are involved in osteoarthritis of the knee. The aim is to investigate if there is a correlation between x-ray results, specific proteins/markers and different types of pain in patients with osteoarthritis of the knee. The study consists of 3 visits over 3-20 days and the last visit will be the day of surgery.
Detailed description
Investigation of Biomarkers in an Exploratory Study in Patients with Osteoarthritis of the Knee Undergoing Total Knee Replacement Surgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with osteoarthritis of the knee | – | –Patients with osteoarthritis of the knee undergoing total knee replacement surgery. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary and secondary care clinics
Key inclusion criteria (2 listed)
- Patients who will undergo a total knee replacement due to osteoarthritis.
- Symptoms of the knee for at least 6 months prior to study start.
Key exclusion criteria (2 listed)
- Key-hole surgery performed on target knee within 3 months prior to study start.
- History of disorders in which part of the immune system is missing or defective.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients with upregulation of IL-6 or the IL-6 signalling pathway in the knee.
Time frame: 3-20 days prior to day 1 (surgery) and day 1 (surgery) .
5 secondary outcomes
Biomarkers in synovial fluid, synovial membrane, and cartilage.
Time frame: Day 1 (surgery).
Biomarkers in blood and urine.
Time frame: 3-20 days prior to day 1 (surgery) and day 1 (surgery).
Biomarkers by Magnetic Resonance Imaging (MRI).
Time frame: 1-5 days prior to day 1 (surgery).
Polymorphisms in 10 specific genes.
Time frame: 3-20 days prior to day 1 (surgery) or at any time in the study.
WOMAC (Western Ontario and McMaster Osteoarthritis Index) variables and NPQ (Neuropathic Pain Questionnaire) variables.
Time frame: 3-20 days prior to day 1 (surgery) and 1-5 days prior to day 1 (surgery).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2012.
- Derived from this study: PubMed 28333699Radojcic MR, Thudium CS, Henriksen K, Tan K, Karlsten R, Dudley A, Chessell I, Karsdal MA, Bay-Jensen AC, Crema MD, Guermazi A. Biomarker of extracellular matrix remodelling C1M and proinflammatory cytokine interleukin 6 are related to synovitis and pain in end-stage knee osteoarthritis patients. Pain. 2017 Jul;158(7):1254-1263. doi: 10.1097/j.pain.0000000000000908.
Related trials for Osteoarthritis of the Knee
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolf Karlsten, MD, PHD study director
AstraZeneca R&D Sodertalje, Sweden
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis of the Knee, run by AstraZeneca at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with upregulation of IL-6 or the IL-6 signalling pathway in the knee. (time frame: 3-20 days prior to day 1 (surgery) and day 1 (surgery) .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01611441, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2012.